Unique ID issued by UMIN | UMIN000031224 |
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Receipt number | R000035660 |
Scientific Title | A clinical study to evaluate the effects of beverage containing green tea catechins on reducing LDL cholesterol |
Date of disclosure of the study information | 2019/02/09 |
Last modified on | 2019/02/13 09:19:30 |
A clinical study to evaluate the effects of beverage containing green tea catechins on reducing LDL cholesterol
A clinical study to evaluate the effects of beverage containing green tea catechins on reducing LDL cholesterol
A clinical study to evaluate the effects of beverage containing green tea catechins on reducing LDL cholesterol
A clinical study to evaluate the effects of beverage containing green tea catechins on reducing LDL cholesterol
Japan |
None
Not applicable | Adult |
Others
NO
To investigate the effects of the intake of beverage containing green tea catechins for 12 weeks on reducing LDL cholesterol
Efficacy
LDL cholesterol
Total cholesterol, HDL cholesterol, LOX-index
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Intake of beverage containing green tea catechins for 12 weeks
Intake of placebo for 12 weeks
20 | years-old | <= |
65 | years-old | > |
Male and Female
1) Subjects whose age of 20 years or more and less than 65 years
2) Subjects whose serum LDL cholesterol levels are 120 mg/dL or more and less than 140 mg/dL (borderline) or 140 mg/dL or more and less than 160 mg/dL (mild Hypercholesterolemia) in the screening examination
3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
1) Subjects receiving a medical treatment for dyslipidemia
2) Subjects having serious hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders
3) Subjects whose fasting serum triglyceride levels are 400 mg/dL or more
4) Subjects who have the possibility of developing allergic symptoms by the test food
5) Subjects who take Foods for Specified Health Uses or Foods with Function Claims labeled the effects of improving LDL cholesterol or total cholesterol levels
6) Subjects who take foods having the effects of improving LDL cholesterol or total cholesterol levels
7) Female subjects who are pregnant or lactating, or intending to be pregnant during the study
8) Female subjects who have menstrual irregularities
9) Subjects who have extremely irregular dietary habits, work in shifts or work during the night
10) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood)
11) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
12) Subjects deemed unsuitable by the investigator
140
1st name | |
Middle name | |
Last name | Takanobu Takihara |
ITO EN, Ltd.
Central Research Institute
21 Mekami, Makinohara, Shizuoka
0548-54-1247
t-takihara@itoen.co.jp
1st name | |
Middle name | |
Last name | Tomohiro Sugino |
Soiken Inc.
Representative Director
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
06-6871-8888
sugino@soiken.com
Soiken Inc.
ITO EN, Ltd.
Profit organization
NO
2019 | Year | 02 | Month | 09 | Day |
Unpublished
Completed
2017 | Year | 11 | Month | 18 | Day |
2018 | Year | 02 | Month | 12 | Day |
2018 | Year | 02 | Month | 09 | Day |
2019 | Year | 02 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035660
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